NXT Post-Market Clinical Follow-up

Urinary Incontinence Clinical Trial

Official title:

NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336304
• Other study ID #: NXTPMCF-01
• Status: Recruiting
• Start date: June 18, 2024
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Laborie Medical Technologies Inc.
• Contact: Kaitlyn Palm
• Phone: 6128160068
• Email: rs.nxtpmcf[@]laborie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations

Description:

The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients medically indicated for urodynamic study

• Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

Exclusion Criteria:

• Patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire

• Patients with confirmed active bladder infections (not including patients with asymptotic bacteria)

• Pregnant women

• Patients with recent (less than 2 weeks) pelvic floor surgery

• Requires use of suprapubic catheter

Related Conditions & MeSH terms

• Enuresis
• Urinary Bladder, Neurogenic
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge
• Urinary Obstruction

Locations

Country	Name	City	State
United States	Chesapeake Urology Hanover	Hanover	Maryland
United States	Chesapeake Urology Owing Mills	Owings Mills	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Laborie Medical Technologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess NXT system performance	Assess the proportion of affirmative responses to the question: did the NXT system successfully measure all necessary urodynamic parameters you required for this patient?	120 Minutes
Primary	Assess NXT system safety	The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.	120 Minutes
Secondary	Assess NXT system performance	Assess the proportion of affirmative responses to the question: Was the urodynamic study completed without any technical failure that prevented its completion?	120 Minutes